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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cup, menstrual
Product CodeHHE
Regulation Number 884.5400
Device Class 2

MDR Year MDR Reports MDR Events
2018 1 1
2019 22 22
2020 220 220
2021 40 40
2022 26 26
2023 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 241 241
Patient Device Interaction Problem 160 160
Adverse Event Without Identified Device or Use Problem 29 29
Insufficient Information 10 10
Patient-Device Incompatibility 10 10
Suction Problem 9 9
Break 8 8
Appropriate Term/Code Not Available 5 5
Compatibility Problem 4 4
Device Dislodged or Dislocated 4 4
Expulsion 3 3
Inadequate Instructions for Non-Healthcare Professional 2 2
Migration or Expulsion of Device 2 2
Product Quality Problem 2 2
Entrapment of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Improper or Incorrect Procedure or Method 2 2
Device Handling Problem 1 1
Output Problem 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Device Slipped 1 1
Sticking 1 1
Difficult to Fold, Unfold or Collapse 1 1
Leak/Splash 1 1
Fitting Problem 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 172 172
Therapeutic Effects, Unexpected 44 44
No Known Impact Or Consequence To Patient 43 43
Pain 33 33
Insufficient Information 28 28
No Clinical Signs, Symptoms or Conditions 24 24
Urinary Tract Infection 13 13
Unspecified Infection 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Prolapse 7 7
No Code Available 7 7
Fungal Infection 6 6
Local Reaction 6 6
Discomfort 5 5
Bacterial Infection 5 5
Hypersensitivity/Allergic reaction 4 4
Laceration(s) 4 4
Abnormal Vaginal Discharge 4 4
Unspecified Reproductive System or Breast Problem 4 4
Intermenstrual Bleeding 4 4
Device Embedded In Tissue or Plaque 4 4
Patient Problem/Medical Problem 4 4
Toxic Shock Syndrome 3 3
Menstrual Irregularities 3 3
Abdominal Pain 3 3
Cyst(s) 2 2
Fever 2 2
Nausea 2 2
Rash 2 2
Irritation 2 2
Hemorrhage/Bleeding 2 2
Skin Irritation 2 2
Not Applicable 2 2
Dysuria 1 1
Skin Tears 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Urinary Incontinence 1 1
Swelling/ Edema 1 1
Missing Value Reason 1 1
Neuralgia 1 1
Genital Bleeding 1 1
Sexual Dysfunction 1 1
Tachycardia 1 1
Renal Failure 1 1
Thrombosis 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Malaise 1 1
Reaction 1 1
Vomiting 1 1
Burning Sensation 1 1
Cramp(s) 1 1
Urinary Frequency 1 1
Distress 1 1
Failure of Implant 1 1
Incontinence 1 1
Micturition Urgency 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Abortion 1 1
Anemia 1 1
Cervical Changes 1 1

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